New psychotherapy for older cancer patients
Cancer and Aging Reflections for Elders (CARE): A Geriatric-Specific Psychotherapy for Older Adults With Cancer
NA · Memorial Sloan Kettering Cancer Center · NCT04452825
This study tests a new phone therapy for older cancer patients to see if it helps reduce their depression and distress better than standard support options.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 459 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04452825 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new psychotherapy intervention called Cancer and Aging: Reflections for Elders (CARE) aimed at treating depression and distress in older cancer patients. Participants aged 70 and above will receive either the CARE intervention or the standard Social Work and Supportive Counseling (SWSC) intervention, both conducted over the phone. The study will compare the effectiveness of these two approaches in alleviating psychological distress associated with cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 70 and above who are currently undergoing cancer treatment or have received treatment in the past six months.
Not a fit: Patients who are currently taking antidepressant medication for less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and quality of life for older cancer patients.
How similar studies have performed: Other studies have shown success with psychotherapy interventions for cancer patients, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* As per self-report or medical record, ≥ 70 years of age
* As per self-report or medical record, has a diagnosis of cancer
* As per self-report or medical record, receiving active treatment (e.g., radiation, chemotherapy, hormone); OR received active treatment in the past 6 months (N/A for training case participants); OR are currently on active surveillance with follow-ups at least approximately every 6 months
* Received a HADS-D score of ≥ 6 or HADS-A score of ≥ 6 or a score of ≥ 4 on the distress thermometer. (N/A for training case participants)
* Received a Karnofsky Performance Rating Scale (KPRS) score of ≥ 60 (N/A for training case participants)
* Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for training case participants)
* Fluent in English, as per self-reported fluency of "well" or "very well"\*
Exclusion Criteria:
* As per self-report, currently taking antidepressant medication for \< 3 months
* As per self-report, currently receiving hospice care
* In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment
* As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
* Language verification: Prior to enrollment, patients will be asked the following two questions by research staff to verify English fluency necessary for participation in the study:
1. How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
2. What is your preferred language for healthcare? (must respond English)
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: William Breitbart, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: William Breitbart, MD
- Email: breitbaw@mskcc.org
- Phone: 646-888-0020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, geriatric cancer, geriatric specific, older adults with cancer, Psychotherapy, Memorial Sloan Kettering Cancer Center, 20-191